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Pfizer and BioNTech's COVID-19 Vaccine Receive the US FDA's Advisory Committee Vote Supporting EUA Against COVID-19

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Pfizer and BioNTech's COVID-19 Vaccine Receive the US FDA's Advisory Committee Vote Supporting EUA Against COVID-19

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  • The US FDA’s VRBPAC voted 17 to 0 with 1 abstention in favor of recommending the EUA for COVID-19 vaccine in children aged 5 to <12yrs. with COVID-19
  • The committee reviewed the P-II/III trial for the COVID-19 vaccine which showed a 90.7% vaccine efficacy in patients without prior SARS-CoV-2 infection @7 Days after 2nd dose- favorable safety profile & robust immune responses. Additionally- patients have received a two-dose regimen of 10-µg doses which was given 21 days apart while ⅓ of the 30-µg dose was used for patients aged 12yrs.
  • If the US CDC’s ACIP grants EUA- Pfizer-BioNTech COVID-19 Vaccine will be the 1st vaccine to be authorized in the US for use in patients aged 5 to <12yrs.

 ­ | Ref: Pfizer | Image: The Wall Street Journal

Click here to­ read the full press release 

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This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

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